Baxter recall Nexterone premixed injection in the United States

Baxter International announced it is voluntarily recalling one lot of Nexterone (amiodarone HCl) 150 mg/100 mL Premixed Injection – distributed between 6/23/2017 and 10/2/2017 in the United States to wholesalers/distributors and healthcare facilities – due to the potential presence of particulate matter” FDA (2017).

FDA report “Baxter International announced it is voluntarily recalling one lot of Nexterone (amiodarone HCl) 150 mg/100 mL Premixed Injection – distributed between 6/23/2017 and 10/2/2017 in the United States to wholesalers/distributors and healthcare facilities – due to the potential presence of particulate matter. The particulate matter may have entered the solution during the manufacturing process. The recalled lot number is NC109925.

The particulate matter was identified by Baxter during a stability study, and was consistent with polyethylene, the primary constituent of the film and ports used to manufacture the bag in which Nexterone is packaged.

Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. The extent and severity of harm depends on the size, number and composition of the foreign material, and the patient’s underlying medical condition. In the absence of in-line filtration, these particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, phlebitis, pulmonary emboli, pulmonary granulomas, immune system dysfunction, pulmonary dysfunction, pulmonary infarction, and systemic embolization.”